Role of MRI in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection

Trial Title: Role of MRI in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection

NCT ID: NCT05787938

Condition: Urinary Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Device
Intervention name: MRI
Description: A procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. A contrast agent, such as gadolinium, may be injected into a vein to help the tissues and organs show up more clearly in the picture. MRI may be used to help diagnose disease, plan treatment, or find out how well treatment is working. It is especially useful for imaging the brain and spinal cord, the heart and blood vessels, the bones, joints, and other soft tissues, the organs in the pelvis and abdomen, and the breast. Also called magnetic resonance imaging, NMRI, and nuclear magnetic resonance imaging.

Summary: To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.

Detailed description: Urinary bladder carcinoma is the second most common tumour of the urinary tract and 70% of such carcinomas are non-muscle-invasive (superficial) at presentation. Transurethral resection (TUR) is the standard treatment; however, recurrence of the tumour is not uncommon so such patients require long-term close supervision. Staging is based on TNM system. Ta tumors are treated with transurethral resection of bladder tumor (TUR-BT). T1 and carcinoma in situ (Tis) tumors have risk of progression and intravesical immunotherapy with Bacillus-Calmette-Guerin (BCG) instillations is used to obtain local control and organ preservation. Invasive bladder cancer (MIBC) is an aggressive disease and standard treatment is radical cystectomy (RC), accompanied by pelvic lymph node dissection (PLND). In addition to radical surgery, neoadjuvant chemotherapy (NAC) has been demonstrated to increase overall survival in MIBC and is recommended by consensus guidelines. Compared to contrast enhanced CT, MRI has better soft tissue contrast which may improve local tumor evaluation. Surveillance strategies for urinary bladder carcinoma recurrence have historically relied on cystoscopy, but this procedure has drawbacks, including its high cost, invasiveness and the fact that it may lead to iatrogenic bladder injury and urinary sepsis. In addition, it cannot diagnose upper tract tumours. The presence of a radiological method that could differentiate between benign and malignant lesions of the bladder would avoid the need for invasive cystoscopy, provided that upper tract tumours were excluded. Diffusion-weighted (DW) MRI is a non-invasive technique measuring the microscopic mobility of water molecules in the tissues without contrast administration. It provides information on perfusion and diffusion simultaneously in any organ, so it can be used to differentiate normal and abnormal structures of tissues, and it might help in the characterization of various abnormalities. During follow-up of patients after trans-urethral resection (TUR), it is difficult to distinguish residual cancer from fibrotic and inflammatory changes secondary to TUR and intravesical chemotherapy, both of which manifest as bladder wall thickening on T2-weighted MRI.

Criteria for eligibility:

Study pop:
Patients who had a history of TUR of superficial bladder tumors. mainly in older people over the age of 55. most common in men, but it's less common in women.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: -Patients who had a history of TUR of superficial bladder tumors and fit for the MRI examination. Exclusion Criteria: - Patients with pacemaker, claustrophobia or metallic prosthesis which are not MRI compatible. - Patients with contraindications for cystoscopy (unfit for anesthesia or urethral stricture). - Patients refusing consent for the study.

Gender: All

Minimum age: 40 Years

Maximum age: 100 Years

Healthy volunteers: No

Start date: April 1, 2023

Completion date: December 1, 2024

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05787938